Blood and Plasma Collection For Use in Future Clinical Trials

Exclusion Criteria

• •Donors that do not meet all Standard-of-Care FDA approved requirements for the donation of blood and production of FFP as determined by the FDA-licensed donor center prior to every donation session may be excluded from further participation in this study. Study exclusion will be determined by the principal investigator (PI) or lead investigator at the study site.
• •Donors that fail the Standard-of-Care screening and Blood Borne Pathogen screening for the following blood borne pathogens at the donor center will be excluded:
• •1. Anti-HIV-I/II
• •2. Anti-human T-lymphotropic virus (HTLV)-I/II
• •3. Anti-hepatitis C (HCV)
• •4. Anti-hepatitis B core antigen (HBc)
• •5. Anti-T. cruzi (enzyme immunoassay \[EIA\] for Chagas disease) (if required by the FDA-licensed donor center or becomes a nationwide FDA requirement)
• •6. Hepatitis B surface antigen (HBsAg)
• •7. Serologic test for syphilis
• •8. HIV nucleic acid test (NAT)
• •9. HCV NAT
• •10. West Nile virus (WNV) NAT
• •Participation in other medical research that includes:
• •1. Studies that are currently ongoing or will start during the duration of this study that require more than 60 mL of blood to be donated in any 56-day period of time
• •2. Administration of any unlicensed drug in the 3 months before study entry or during the duration of this study
• •3. Administration of any unlicensed vaccine in the 12 months before study entry or during the duration of this study, with the exception of unlicensed influenza vaccine